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Expert Opinion

Volume 76, Issue 12, September 2020

JOURNAL：J Am Coll Cardiol.

Article Link

Trial Design Principles for Patients at High Bleeding Risk Undergoing PCI: JACC Scientific Expert Panel

D Capodanno, MC Morice, DJ Angiolillo et al.

3925

Keywords: trial design; high bleeding risk; PCI

ABSTRACT

Investigating the balance of risk for thrombotic and bleeding events after percutaneous coronary intervention (PCI) is especially relevant for patients at high bleeding risk (HBR). The Academic Research Consortium for HBR recently proposed a consensus definition in an effort to standardize the patient population included in HBR trials. The aim of this consensus-based document, the second initiative from the Academic Research Consortium for HBR, is to propose recommendations to guide the design of clinical trials of devices and drugs in HBR patients undergoing PCI. The authors discuss the designs of trials in HBR patients undergoing PCI and various aspects of trial design specific to HBR patients, including target populations, intervention and control groups, primary and secondary outcomes, and timing of endpoint reporting.